Nexdrive™ MI-2000 (UDI 00613994747860)Recalls & reported problems
Medtronic, Inc. · ACCY MI-2000 NEXDRIVE MANUAL GLOBAL AIMD · Class 2
All models of Nexdrive (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994747860), received between Sep 7, 2017 and Sep 7, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K022100); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Device Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected
A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE MEASUREMENT TAPE WAS MISALIGNED ON THE MICRO-POSITIONING SYSTEM. THE MISALIGNMENT BETWEEN RED AND BLUE COLOR WAS NOT EXACTLY AT ZERO. NO TROUBLESHOOTING OR DIAGNOSTICS WERE REPORTED. NO ACTIONS WERE TAKEN TO RESOLVE THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO MEDICAL SYMPTOMS WERE REPORTED. THE PATIENT WAS IMPLANTED FOR UNKNOWN SYMPTOMS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6849814 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K022100. One submission often covers many models, so check the product and lot details in each record.
- Z-2118-2014 · Jun 11, 2014 · TerminatedMedtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of micr
- Z-0849-2008 · Oct 4, 2007 · TerminatedNexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, DB-1043, DB-1043-
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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